Senior Regulatory Affairs Specialist - Remote

Overview

The Senior Regulatory Affairs Specialist is responsible for providing regulatory affairs and product development consulting services to pharmaceutical, medical, and biotechnology companies, ensuring compliance with government regulations and facilitating regulatory approvals.

In Short

• Collaborate with internal regulatory partners on product development projects.
• Maintain regulatory information to support customer queries and submissions.
• Provide regulatory support for various business units and medical devices.
• Maintain regulatory data and generate necessary reports.
• Assist in interpreting and evaluating proposed regulations for medical devices.
• Support the preparation and maintenance of global product registrations.
• Develop and implement regulatory procedures.
• Work collaboratively in a team environment.
• Travel required up to 10%.
• Effective project management and communication skills are essential.

Requirements

• Bachelor's degree in a related field preferred.
• 2+ years of experience in Medical Device Regulatory Affairs/Quality preferred.
• Certification in regulatory affairs program preferred.
• Effective problem-solving skills.
• Ability to create cross-functional partnerships.
• Strong oral and written communication skills.
• Ability to work collaboratively in a team environment.

Benefits

• Medical, dental, and vision coverage.
• Paid time off plan.
• Health savings account (HSA).
• 401k savings plan.
• Access to wages before payday with myFlexPay.
• Flexible spending accounts (FSAs).
• Short- and long-term disability coverage.
• Work-Life resources.
• Paid parental leave.
• Healthy lifestyle programs.